Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Irinotecan

Taxane

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks

+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks

Irinotecan, Capecitabine

Jungsil Ro

Inhae Park

This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast cancer patients previously treated with anthracycline and taxane.

Prior to enrollment, patients will be confirmed for hormone and HER2 receptor status. Patients may have either measurable and/or evaluable metastatic lesions which are able to be assessed by chest, abdomen CT and bone scan performed within 28 days prior to start of treatment.

* Capecitabine alone arm: 1250 mg/m2, BID, day 1-14, every 3 weeks
* Irinotecan plus capecitabine arm : Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks + capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks.

Randomization will be done using a random block size permutation method and stratified based on : hormone receptor status (negative vs. positive), first line vs. more than second lines, visceral metastasis (negative vs. positive).

Treatment will continue until disease progression, death, or discontinuation due to side effects of drugs or refusal by patients.

The primary objective of this study is to estimate the PFS of capecitabine and irinotecan in patients with anthracycline and taxane- pretreated metastatic breast cancer, which will be estimated by the Kaplan-Meier method and compared by log-rank test. Overall survival will be also estimated by same method. The secondary statistical analysis consisting of an estimation of the complete and partial response rates and response rates of the treatment will be calculated as the ratio of the number of complete and partial responders to the total number of evaluable patients and toxicity profile, which will be estimated as the ratio of the number of occurrence to the total number of evaluable patients. A 95% confidence interval for the response rate is computed based on the binomial distribution function. The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months. The overall survival and progression free survival, and their respective medians will be estimated with 95% confidence intervals.

Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer

Phase III Multicenter Randomized Open-label Study of Irinotecan Plus Capecitabine Versus Capecitabine in Patients Previously Treated With Anthracycline and Taxane for HER2 Negative Metastatic Breast Cancer[PROCEED]

Day between the date of enrollment to the date of disease progression or death

Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine

Asan Medical Center

Chung-Ang University

Inha University Hospital

Korea University Anam Hospital

Samsung Medical Center

Severance Hospital

Seoul National University Hospital

Seoul National University Bundang Hospital

National Cancer Center, Korea

Chief, Center for Clinical Trials, National Cancer Center, Korea

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

David Cunningham

The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen containing irinotecan combined with capecitabine in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or stomach who have previously received chemotherapy and have either failed to respond or who have relapsed within 3 months after an initial response will be eligible for treatment in this study.

The response rate, failure-free survival and overall survival of treated patients will be evaluated. Toxicity and quality of life will also be monitored closely.

Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours

A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours

Royal Marsden NHS Foundation Trust

Jane Lawrence

Symptoms and General Pathology

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.

irinotecan, capecitabine

Jin Li, PhD

The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.

Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.

Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients

Fudan University

Kyung Hae Jung, M.D.

This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.

Response assessment will be performed every 3 cycles of chemotherapy.

Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer	NCT01501669	Metastatic Brea...	Irinotecan, Cap...	20 Years -	National Cancer Center, Korea
Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours	NCT00220168	Upper Gastroint...	Irinotecan, Cap...	18 Years -	Royal Marsden NHS Foundation Trust
Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours	NCT00220168	Upper Gastroint...	Irinotecan, Cap...	18 Years -	Royal Marsden NHS Foundation Trust
Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer	NCT01322152	Colorectal Canc...	irinotecan, cap...	18 Years - 70 Years	Fudan University
Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer	NCT00506168	Colorectal Neop... Secondary Drug Therapy, C...	Irinotecan, Cap...	18 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for irinotecan, capecitabine